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Friday, February 17, 2012

Generic Leadership Fine for EHR Implementation in High Acuity, High Risk Areas Such as an Emergency Department?

1. Not all H-IT safety issue MDRs can be captured due to limitations of reporting practices including

... (a) Vast number of H-IT systems that interface with multiple medical devices currently assigned to multiple procodes making it difficult to identify specific procodes for H-IT safety issues;... (b) Procode assignments are also affected by the ability of the reporter/contractor to correctly identify the event as a H-IT safety issue;... (c) Correct identification by the reporter of the suspect device brand name is challenged by difficulties discerning the actual H-IT system versus the device it supports.

2. Due to incomplete information in the MDRs, it is difficult to unduplicate similar reports, potentially resulting in a higher number of reports than actual events.

3. Reported death and injury events may only be associated with the reported device but not necessarily attributed to the device.

4 Correct identification by the reporter of the manufacturer name is convoluted by the inability to discern the manufacturer of the actual H-IT system versus the device it supports.

5 The volume of MDR reporting to MAUDE may be impacted by a lack of understanding the reportability of H-IT safety issues and enforcement of such reporting.

... The results of this data review suggest significant clinical implications and public safety issues surrounding Health Information Technology. The most commonly reported H-IT safety issues included wrong patient/wrong data, medication administration issues, clinical data loss/miscalculation, and unforeseen software design issues; all of which have varying impact on the patient’s clinical care and outcome, which included 6 death and 43 injuries. The absence of mandatory reporting enforcement of H-IT safety issues limits the number of relevant MDRs and impedes a more comprehensive understanding of the actual problems and implications.

Finally, as I pointed out in my Dec. 2009 post "ONC Defines a Taxonomy of Robust Healthcare IT Leadership", the Office of the National Coordinator for Health IT at HHS (ONC) had published the following with regard to the qualification of those who could "lead the successful deployment and use of health IT to achieve transformational improvement in the quality, safety, outcomes, and thus in the value, of health services in the United States":

Clinician/Public Health Leader: By combining formal clinical or public health training with training in health IT, individuals in this role will be able to lead the successful deployment and use of health IT to achieve transformational improvement in the quality, safety, outcomes, and thus in the value, of health services in the United States. In the health care provider settings, this role may be currently expressed through job titles such as Chief Medical Information Officer (CMIO), Chief Nursing Informatics Officer (CNIO). In public health agencies, this role may be currently expressed through job titles such as Chief Information or Chief Informatics Officer. Training appropriate to this role will require at least one year of study leading to a university-issued certificate or master’s degree in health informatics or health IT, as a complement to the individual’s prior clinical or public health academic training. For this role, the entering trainees may be physicians or other clinical professionals (e.g. advanced-practice nurses, physician assistants) or hold a master’s or doctoral degree(s) in public health or related health field. Individuals could also enter this training while enrolled in programs leading directly to degrees qualifying them to practice as physicians or other clinical professionals, or to master’s or doctoral degrees in public health or related fields (such as epidemiology). Thus, individuals could be supported for training if they already hold or if they are currently enrolled in courses of study leading to physician, other clinical professional, or public-health professional degrees.

Here, though, is a more typical reality in today's hospitals, the background of an EHR deployment leader in one of the most risk-prone and difficult environments in healthcare, the Emergency Department (ED) in a large hospital of which I am aware:

Clinical Systems Analyst

January 2004 – Present

Project manager for implementation of an ED EHR [vendor name redacted]Responsible for all aspects of implementation including build and process design, report build, testing, training, and go-live support.Extensive knowledge ADT processes, HL7, and CPOE.Manage software patches and upgrades.Experience in HTML, SQL and SAP.

Financial Systems AnalystNovember 2001 – January 2004

Project Team Lead for implementation of Patient Accounting system.Responsible for system development and system build, training, testing, and reporting.

Education

[Regional university in the lower 50% of US News rankings in the region, name redacted]B.S., Management Information Systems2000 – 2003

[Name redacted] Community College

Associates Degree, Business Administration

So, ED physicians (with many years of doctoral and post-doctoral training and experience, boards testing their competence, etc.) may be placing the lives of patients and their careers in the hands of:

An experimental medical device,

unregulated by anyone,

in a field whose qualifications for leadership are unregulated by anyone,

devices known to be risky,

but without anyone knowing the magnitude of that risk,

whose implementation is led by a generic 'clinical' systems analyst "responsible forall aspects of implementation" with a Bachelor's degree in MIS from a second-tier institution, an Associates degree from a community college, and no medical or Medical Informatics education or experience whatsoever.

Further, that project lead jumped from financial systems analyst to 'clinical' analyst/leader of an ED EHR implementation.

One should also ask

Who was the hiring manager who hired such a person and put them in the role?

On what credentials and experience was the decision based?

What were the hiring manager's own credentials?

I leave it to the reader to decide if this is an appropriate arrangement, and if they would place their trust in an ED whose activities center around a cybernetic system implemented in this manner.

I don't think a degree gets you anything," says healthcare recruiter Lion Goodman, president of the Goodman Group in San Rafael, California about CIO's and other healthcare MIS staffers. Healthcare MIS recruiter Betsy Hersher of Hersher Associates, Northbrook, Illinois, agreed, stating "There's nothing like the school of hard knocks."In seeking out CIO talent, recruiter Lion Goodman "doesn't think clinical experience yields [hospital] IT people who have broad enough perspective. Physicians in particular make poor choices for CIOs. They don't think of the business issues at hand because they're consumed with patient care issues," according to Goodman.

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